In the post-Kessler era, the industry is looking ahead to reform in labeling and to unhampered, speedy approval of drug applications.
Drug approvals should continue to be a priority at the Food and Drug Administration, said Bill Marth, director of pharmacy, Price Chopper Supermarkets, Schenectady, N.Y.
"The FDA has done a great job but they can always do more, such as speed up approval of ANDAs [an abbreviated new drug application] for generics," he said. "As long as we don't compromise safety and efficacy, then drugs should be approved as quickly as possible in order to lower total health-care costs."
Although Dr. David Kessler will be favorably remembered for promoting self-care and bringing new drugs to the market, the FDA commissioner, who announced last month he would leave his post next year, did confront the pharmacy industry with some unpopular issues.
Ron Ziegler, president and chief executive officer of the National Association of Chain Drug Stores, Alexandria, Va., agreed it will be important for the new commissioner to continue the speedy review process for new prescription drugs, and to recognize the legitimate limitations on the agency's authority and ability to regulate the practice of pharmacy.
The FDA created a furor, Marth noted, when it announced that it was considering a proposal to regulate medication guidance sheets that pharmacists give to patients. "Most chains give out the medication sheets -- the market has made it a standard within the industry," he said. "There were many people in the industry who didn't want government intervention. It becomes an issue of over-regulation. The FDA back-burned their recommendation."
Kessler also took issue with the practice of compounding, where pharmacists mix certain medications according to a doctor's specifications. "Pharmacists are trained in compounding, but the FDA was concerned that compounds are unapproved medications or unapproved uses," Marth said. "It's of so minimal importance that it shouldn't get FDA concern."
There are bigger issues that need resolving, said industry executives. Over-the-counter label reform, for example, which has been under development at the FDA for some time, is expected to come in the near future.
"Looking ahead, we expect a proposed rule to be published soon -- perhaps before Dr. Kessler departs -- which should make OTC labels even easier to read and more user-friendly," said James D. Cope, president of the Washington-based Nonprescription Drug Manufacturers Association (NDMA).
"We have been working closely with the FDA on pharmacy issues, labeling, food safety and consumer education," said Edie Clark, a spokeswoman for the Washington-based Food Marketing Institute (FMI). "We are looking forward to continuing that close relationship with the agency."
"Dr. Kessler chided the pharmacy profession and pushed us when we had failings," said Dr. John A. Gans, executive vice president of the American Pharmaceutical Association (APhA), Washington. "I think the profession of pharmacy is beginning to respond and reinvent itself around the whole issue of care-giving, communication, management and working with patients to make sure they understand and utilize drug products more effectively. He has challenged the profession of pharmacy and I think we have tried to respond."